cytarabine in treating young patients with recurrent or refractory ewing's sarcoma

Conditions: Sarcoma

Summary: rationale: drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well cytarabine works in treating young patients with recurrent or refractory ewing's sarcoma.

objectives: * determine the response rate in younger patients with recurrent or refractory ewing's sarcoma treated with cytarabine. outline: this is a multicenter study. patients receive cytarabine iv over 2 hours twice daily on days 1-5. treatment repeats every 21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed periodically for 5 years. projected accrual: a total of 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed ewing's sarcoma or primitive neuroectodermal tumor (pnet) * disease that has recurred or not responded despite prior therapy * has declined enrollment on or is not eligible for clinical trial cog-aews0521 * must have at least one site of measurable disease involving lung or soft tissue as documented by ct scan and/or mri * no disease limited to bone patient characteristics: * karnofsky performance status (ps) 50-100% (for patients \> 16 years of age) or lansky ps 50-100% (for patients ≤ 16 years of age) * life expectancy ≥ 8 weeks * anc ≥ 750/mm\^3 * platelet count ≥ 75,000/mm\^3 (50,000/mm\^3 if documented bone marrow metastatic disease) (transfusion independent) * hemoglobin ≥ 8.0 g/dl (red blood cell transfusions allowed) * bilirubin ≤ 1.5 times upper limit of normal (uln) for age and \< 2.0 mg/dl * alt ≤ 2.5 times uln * creatinine clearance or radioisotope gfr ≥ 70 ml/min or creatinine meeting the following criteria: * ≤ 0.4 mg/dl (1 month to \< 6 months of age) * ≤ 0.5 mg/dl (6 months to \< 1 year of age) * ≤ 0.6 mg/dl (1 to \< 2 years of age) * ≤ 0.8 mg/dl (2 to \< 6 years of age) * ≤ 1.0 mg/dl (6 to \< 10 years of age) * ≤ 1.2 mg/dl (10 to \< 13 years of age) * ≤ 1.4 mg/dl (≥ 13 years of age) (female) * ≤ 1.5 mg/dl (13 to \< 16 years of age) (male) * ≤ 1.7 mg/dl (≥ 16 years of age) (male) * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no uncontrolled infection, including systemic fungal infections requiring ongoing antifungal therapy prior concurrent therapy: * see disease characteristics * recovered from all prior tumor-directed therapy * at least 7 days since prior biologic therapy or immunotherapy * at least 1 week since prior hematopoietic growth factors (2 weeks for pegfilgrastim) * at least 2 weeks since prior myelosuppressive chemotherapy * at least 2 weeks since prior local palliative (small-port) radiotherapy * at least 6 weeks since prior substantial bone marrow radiotherapy * at least 6 months since prior radiotherapy to ≥ 50% of the pelvis * at least 6 months since prior autologous stem cell transplantation * no prior allogeneic stem cell transplantation * no prior cytarabine * no other concurrent investigational agents, including chemotherapy, immunotherapy, or biologic therapy * no other concurrent anticancer chemotherapy or immunomodulating agents * concurrent corticosteroids allowed * no concurrent intrathecal chemotherapy * concurrent radiotherapy to localized painful lesions allowed provided at least one measurable lesion is not irradiated (no irradiated lesion may be used to assess tumor response)

Keywords: recurrent ewing sarcoma/peripheral primitive neuroectodermal tumor